From 20 January 2027, machinery placed on the EU market falls under Regulation (EU) 2023/1230, which replaces Machinery Directive 2006/42/EC. For a machine builder that is an obvious change. For a manufacturing plant that modernises its own equipment it is less obvious and more awkward: with a deep enough rebuild, you become the manufacturer of the machine and you issue the paperwork. Below is an overview of what changes in practice for a retrofit project. It is an orientation piece — the legal text governs.
A regulation instead of a directive: why it matters
Directive 2006/42/EC had to be transposed into national law and left member states room for interpretation. Regulation (EU) 2023/1230 applies directly and identically across the Union. The practical effect is mundane but real: you stop hunting for the national equivalent of a provision and start reading one text — the same one your German customer and your Italian component supplier work from.
The application date is 20 January 2027. The transitional details — what happens to machines designed earlier and delivered later — have to be checked in the regulation itself, because this is exactly the point where generalisations get expensive. If your investment crosses that date, ask the supplier plainly which legal regime the documentation will be issued under.
Who counts as the manufacturer
The manufacturer is the party that makes a machine, or has it designed or made, and places it on the market under its own name or trade mark. That party is responsible for the risk assessment, the technical file, conformity assessment, the declaration, CE marking and the instructions. Importers and distributors have narrower duties, but not none: they amount to checking that the manufacturer did its job and not removing what it supplied.
The point that matters for plants: you can become a manufacturer without meaning to. It happens in two ways — by combining several machines into an assembly, or by changing an existing machine in a way the rules treat as substantial.
Substantial modification: when the plant becomes the manufacturer
The regulation puts the concept of substantial modification into the legal text: a change to a machine already on the market, not foreseen by its manufacturer, that creates a new hazard or increases an existing risk. Whoever makes such a modification takes on the manufacturer's duties for it.
What does that mean for a typical retrofit? Swapping a controller for a newer one while keeping the same function, the same speeds and the same safety functions usually creates no new hazard. The candidates for substantial modification are different: raising line throughput, adding a station or a feeder, changing how a safety function is implemented, enabling automatic operation where control used to be manual, and opening a channel that allows setpoints to be changed from outside the machine.
The assessment is always case-by-case, and its result has to be documented even when it reads "this modification is not substantial". A missing note is worse than an inconvenient conclusion, because after an inspection or an accident there is nothing to justify the decision with. The planning consequence: the classification is made at concept stage, not after commissioning. The scope of work that decides it is described on the production line modernisation and machine retrofit page.
Cybersecurity of safety functions
The most significant novelty for a control engineer: the regulation explicitly covers protecting the machine against deliberate third-party action, to the extent that such action could compromise safety. Safety-related control systems are to resist accidental and deliberate damage or alteration, and safety-relevant software and data are to be protected against unauthorised modification, with such an attempt being detectable.
In a retrofit project that turns into specifics: access control to the controller and to the engineering environment, logging of program changes, separation of the machine network from the office network, and a controlled service channel instead of a permanently connected modem. We describe how to build that in the guide to secure remote service access.
Behaviour shaped by learning systems
The regulation also addresses machines whose safety-relevant behaviour is shaped by self-learning systems — those that change how they act during operation. The thrust of the requirements is predictability: behaviour is to stay within the limits set by the manufacturer, and changes are to be traceable and reproducible.
In Polish retrofits this touches few projects today, most often machine-vision quality inspection, and only where its verdict stops the machine or blocks release of the product. If your project has none of it, noting that in the assessment is enough. If it does, it is a conversation to have with a notified body early, not two weeks before start-up.
Instructions in digital form
The regulation allows instructions to be supplied digitally, which settles a long argument about ring binders parked next to the machine. It is not, however, permission to send a link in an email: digital instructions are to remain available for a defined period, in a format that can be downloaded and saved, and the user keeps the right to a paper version on request. The scope of information that must still be supplied in print, and the details of how access to the digital version is marked, are set by the regulation text — one of the points worth reading in the original before it goes into a purchase specification.
For a plant that becomes the manufacturer after a substantial modification, this is a duty of its own: the instructions describe the machine as changed, in the local language, and they cover the parts you never touched as well.
Risk assessment and PN-EN ISO 13849-1
The methodology does not change dramatically. The starting point remains the risk assessment and, for the safety-related parts of the control system, determining the required performance level and demonstrating that the implemented system reaches it. The base standard on the Polish market remains PN-EN ISO 13849-1; for electronic and programmable systems the IEC 62061 family applies as well. What is new is that hazards arising from deliberate interference now enter the calculation explicitly, not just failures and human error.
A risk assessment is a living document: it is produced before the project, verified after the system is validated and updated at every subsequent change to the machine. A 2011 version in a binder is not the risk assessment of a machine rebuilt last month.
What a retrofit project must document
- the machine's starting state: manufacturer documentation, declaration, instructions, the history of earlier changes;
- a description of the change and a reasoned classification of whether it is a substantial modification;
- the risk assessment before and after the change;
- the safety function specification with required and achieved performance levels, including the calculations;
- a description of the measures protecting safety-relevant software and data, and of the service-access rules;
- the safety validation protocol with measurements, stopping times included;
- the technical file, declaration of conformity and marking — where the modification proved substantial;
- the instructions as changed and evidence that operators were trained.
That list doubles as the line items of a request for quotation. A control-rebuild offer that does not price the risk assessment, the validation and the documentation is only cheaper on paper: the missing items come back in the last week of the project, when nobody has time left for them. The scope in which we run them alongside the technical work is described on the industrial automation page.
What to do this year
- Review planned investments and mark the ones that cross 20 January 2027. For those, agree the documentation regime with the supplier before you sign the order.
- Collect the documentation for the machines you are most likely to modernise. Gaps are better found now than during a conformity assessment.
- Decide internally who classifies a modification: maintenance, the safety officer or the technical department. Settling that after the fact is the most expensive option.
- Put the software-protection and service-access requirements into your standard purchasing terms instead of negotiating them project by project.
A closing caveat: this is an engineering overview, not legal advice. What a specific project owes is settled by the text of Regulation (EU) 2023/1230 and, in case of doubt, by a notified body or a lawyer. We quote no article or annex numbers here, because they are easy to get wrong in an overview and a mistake at that point is costly.